Iron Bioavailability From Fortified Food

Nestlé

Status: Completed

Conditions: Iron Bioavailability

Treatments: Other: Labeled iron salt Fe54; Other: Labeled iron salt Fe57; Other: Labeled iron salt Fe58

Study type: Interventional

Funder types: Industry

Identifiers

NCT02993835

16.15.NRC

Details and patient eligibility

About

Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds.

Full description

This single center trial will be single-blind to the subject, controlled, fully randomized with crossover design in 22 healthy females aged 18-40 years old.

Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after last stable isotope intake blood sampling (V7).

Enrollment: 23 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women aged 18-40 years old
2. Healthy, based on the medical screening visit including a blood formula
3. Normal BMI for age (18.5-25.0 kg/m2)
4. Weight less than 65 kg
5. Able to understand and to sign written informed consent prior to trial entry
6. Informed consent signed

Exclusion criteria

1. Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
2. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
3. Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
4. Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
5. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
6. Diagnosed food allergy.
7. Pregnancy (tested in plasma at screening) and/or lactation.
8. History of cancer within the past year.
9. Significant weight loss during the last 3 months (10% and more)
10. Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
11. Iron supplementation therapy or perfusion in the last three months.
12. Smokers (> 5 cigarettes per day).
13. Have a high alcohol consumption (more than 2 drinks/day).
14. Consumption of illicit drugs (anamnesis only).
15. Subject having a hierarchical link with the investigator or co-investigators.
16. Subject who cannot be expected to comply with treatment or study procedure.
17. Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
18. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

23 participants in 3 patient groups

Labeled iron salt (Fe54)

Active Comparator group

Description:

Labeled iron salt (Fe54) with bouillon

Treatment:

Other: Labeled iron salt Fe54

Labeled iron salt (Fe57)

Active Comparator group

Description:

Labeled iron salt (Fe57) with bouillon

Treatment:

Other: Labeled iron salt Fe57

Labeled iron salt (Fe58)

Experimental group

Description:

Labeled iron salt (Fe58) with bouillon

Treatment:

Other: Labeled iron salt Fe58